Respiratory mask with nasogastric tube path

ABSTRACT

A respiratory mask can be used to provide therapy to patients who also require a nasogastric (NG) tube. The mask seal can include a path that is designed to deform around an NG tube or other without lifting the mask away from a patient&#39;s face. The deforming path can help to minimize gaps that form between the patient&#39;s face and the mask seal as a result of the tube, thus reducing leaks and improving the efficacy of the treatment.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis made are hereby incorporated by reference and made a part of thepresent disclosure.

BACKGROUND

Field

The present disclosure generally relates to respiratory masks, such asthose intended for use in non-invasive ventilation (NIV). Moreparticularly, the present disclosure relates to a seal or cushion for anNIV mask or other mask that enhances the sealing capabilities of themask when used in combination with a tube, such as a nasogastric (NG)tube, a nasojejunal (NJ) tube and/or an oro-gastric (OG) tube, forexample.

Description of Related Art

NIV masks commonly are used on patients who also require an NG, NJand/or OG tube for feeding or delivery of medication. Traditionally, NIVmasks are not designed for use in combination with an NG, NJ and/or OGtube and, as such, the efficacy of the NIV therapy can be compromisedwhen such a combination is desired.

Traditional NIV masks have a silicone or thermoplastic elastomer (TPE)seal/cushion that conforms to a patient's face in order to create anair-tight seal. These cushions generally are flexible but not to anextent that allows the cushion to conform to very small features. Incircumstances where an NG, NJ and/or OG tube is desired to be used incombination with an NIV mask, it is typical for the mask to be placedover the top of the tube(s). The tube(s) lift the cushion away from thepatient's face, creating gaps around the tube that cause the seal to bebroken and allow leaks to occur.

There are several techniques currently used to minimize gaps and toreduce leaks. These techniques include strapping the mask tighter ontothe patient, using an adhesive pad to fill the gaps between the tube,cushion and patient's face, or passing the NG, NJ and/or OG tube througha port in the mask. Strapping the mask tighter can be uncomfortable forthe patient and can lead to pressure-related skin damage. It also ispossible that the NG, NJ and/or OG tube may be deformed by the tight fitof the mask and this could lead to blockages within the tube. The use ofan adhesive pad creates extra work for the clinician who is fitting theNG tube or other tube and mask because it is another component that hasto be fitted and aligned. In addition, the pad may not be successful inblocking the gaps effectively if the tube is too large or small or ifthe tube and/or the pad are misaligned. Passing the NG, NJ and/or OGtube through a port in the mask eliminates any breaks in the seal causedby the tube but often requires the tube to be removed in order to removethe mask. Removing and replacing NG, NJ and/or OG tubes can beuncomfortable and can cause irritation to the patient.

SUMMARY

The systems, methods and devices described herein have innovativeaspects, no single one of which is indispensable or solely responsiblefor their desirable attributes. Without limiting the scope of theclaims, some of the advantageous features will now be summarized.

Certain features, aspects and advantages of the embodiments include arespiratory mask with a cushion that is designed to accommodate an NG,NJ and/or OG tube passing between the mask and a patient's face. Thecushion has specific thin regions that are designed to conform to thegeometry of an NG, NJ and/or OG tube, which regions can help to reduceor minimize leak-causing gaps that might be otherwise created betweenthe cushion and the patient's face.

In some configurations, a cushion for a respiratory mask includes a facecontacting portion and at least one thin region at least partiallywithin the face contacting portion. The thin region is adapted toaccommodate the placement of a tube between the face contacting portionand a face of a user.

In some configurations, in use, the at least one thin region is adaptedto conform to a shape of the tube while substantially maintaining anadequate seal with the face of the user.

In some configurations, the at least one thin region is located on alateral side of the face contacting portion.

In some configurations, the at least one thin region comprises a thinregion on each lateral side of the face contacting portion.

In some configurations, the thin region on one lateral side is arelatively larger thin region and the thin region on the other side is arelatively smaller thin region.

In some configurations, the at least one thin region comprises two ormore thin regions on one lateral side of the face contacting portion. Insome configurations, a first thin region and a second thin region of thetwo or more thin regions are spaced apart from one another. In someconfigurations, the first thin region and the second thin region arespaced apart along a perimeter of the face contacting portion. In someconfigurations, the two or more thin regions comprise at least onerelatively larger thin region and at least one relatively smaller thinregion.

In some configurations, the at least one thin region extends in adirection from an inner edge of the face contacting portion toward anouter edge of the face contacting portion.

In some configurations, the at least one thin region extends downwardlyrelative to a horizontal axis from an inner end portion to an outer endportion. In some configurations, the at least one thin region extendsdownwardly at an angle of between about 5 degrees and about 45 degrees.

In some configurations, the cushion includes a smooth transition inthickness between the at least one thin region and an adjacent portionof the face contacting portion. In some configurations, the transitionis substantially linear.

In some configurations, a thickness of the at least one thin region isbetween about 5 percent and about 80 percent of a thickness of anadjacent portion of the face contacting portion. In some configurations,the thickness of the at least one thin region is between about 10percent and about 30 percent of the thickness of the adjacent portion ofthe face contacting portion.

In some configurations, end portions of the at least one thin region arerounded.

In some configurations, the inner end portion of the at least one thinregion is spaced outwardly from the inner edge of the face contactingportion.

In some configurations, the outer end portion of the at least one thinregion is spaced inwardly from the outer edge of the face contactingportion.

In some configurations, the tube is a feeding tube.

In some configurations, the cushion comprises a visual alignmentindicator that indicates a proper location of the tube.

In some configurations, a patient interface includes a cushioncomprising a face contacting portion and at least one thin region atleast partially within the face contacting portion. The thin region isadapted to accommodate the placement of a tube between the facecontacting portion and a face of a user.

In some configurations, the cushion is adapted to create a seal aroundthe user's nose and/or mouth.

In some configurations, the cushion is configured such that an upperportion of the cushion can be deflected forward relative to a lowerportion of the cushion.

In some configurations, a headgear retains the patient interface on thehead of a user. In some configurations, a frame portion interfaces withthe headgear and the cushion interfaces with the frame portion.

In some configurations, the cushion comprises a relatively soft portiondefining the face contacting portion and a relatively rigid portionfacing away from the relatively soft portion.

In some configurations, the at least one thin region is located on alateral side of the face contacting portion.

In some configurations, the at least one thin region comprises a thinregion on each lateral side of the face contacting portion.

In some configurations, the at least one thin region comprises two ormore thin regions on one lateral side of the face contacting portion.

In some configurations, the at least one thin region extends downwardlyrelative to a horizontal axis from an inner end portion to an outerportion.

In some configurations, the cushion includes a smooth transition inthickness between the at least one thin region and an adjacent portionof the face contacting portion.

In some configurations, a thickness of the at least one thin region isbetween about 5 percent and about 80 percent of a thickness of anadjacent portion of the face contacting portion. In some configurations,the thickness of the at least one thin region is between about 10percent and about 30 percent of the thickness of the adjacent portion ofthe face contacting portion.

In some configurations, the patient interface includes a visualalignment indicator that indicates a proper location of the tube.

BRIEF DESCRIPTION OF THE DRAWINGS

Throughout the drawings, reference numbers can be reused to indicategeneral correspondence between reference elements. The drawings areprovided to illustrate example embodiments described herein and are notintended to limit the scope of the disclosure.

FIG. 1 shows a view of a patient wearing a respiratory mask (e.g., anNIV mask) arranged and configured in accordance with certain features,aspects and advantages of the present disclosure in combination with atube (e.g., an NG tube) that extends down and out of the lower left sideof the mask as viewed by the patient.

FIG. 2 is a profile view of a seal or cushion of the mask of FIG. 1adapting or conforming to an NG tube in comparison to a regular maskshown in dashed line.

FIG. 3 is a profile view of the cushion of the mask of FIG. 1 with no NGtube present.

FIG. 4 is a perspective view of a portion of the mask of FIG. 1illustrating a rounded profile of a thin region of the cushion.

FIG. 5 is a rear view of a portion the mask of FIG. 1 illustrating anangled orientation of the thin region of the cushion.

FIG. 6 is a rear view of a portion of the mask of FIG. 1 sectionedthrough a portion of the cushion containing the thin region.

FIG. 7 is an enlarged view of the sectioned portion of the cushioncontaining the thin region of FIG. 6.

FIG. 8 is a sectioned view of the portion of the cushion containing thethin region taken along line 8-8 of FIG. 6.

FIG. 9 is an outline of a shape of a thin region in a flattenedcondition.

FIG. 10 is a rear view of a mask that shows a pair of thin regions oneach side of the cushion, wherein the thin regions of the same side aredifferently sized and the thin regions are symmetrical between thesides.

FIGS. 11A and 11B are perspective views of portions of two differentmasks having different types of visual alignment indicators tofacilitate positioning of the tube relative to the cushion.

DETAILED DESCRIPTION

In circumstances where NG, NJ and/or OG tubes are used in combinationwith NIV masks, undesirably high leak rates are a common occurrence.Having high leak rates can compromise the quality of therapy that apatient receives and the methods currently used to remedy the leaks canresult in undesirable side-effects. Certain features, aspects andadvantages of the disclosed embodiments seek to provide a usefulalternative to currently known approaches of addressing and reducingthese leaks.

The following description of certain features, aspects and advantages ofcertain embodiments refers to respiratory masks designed and configuredto be used, or adapted for use, in combination with an NG tube; however,it is to be understood that the mask also can be used in combinationwith an NJ tube, both an NG tube and an NJ tube, which is more common,or any combination of an NJ tube, NG tube or OG tube. The respiratorymasks can also be used, or adapted for use, with other types of tubesthat are desired to pass between the mask cushion or seal and thepatient's skin. Therefore, references to NG tubes herein can also referto NJ tubes, OG tube, other tubes (e.g., fluid draining tubes) or anycombination of NG tubes, NJ tubes, OG tube and other tubes.

The illustrated respiratory masks are NIV masks; however, the features,aspects and advantages described herein can be applied to other types ofmasks, as well. Certain features, aspects and advantages of the presentmasks are described in relation to providing therapy to adults; however,it also is possible to apply certain features, aspects and advantages ofthe present disclosure to respiratory masks for any age group, includingbut not limited to neonatal, infant and pediatric patients.

FIG. 1 illustrates a user or patient 50 wearing a respiratory (e.g.,NIV) mask 52 in combination with an NG tube 54. The illustrated mask 52includes a mask body or interface 56, which includes a cushion or seal58 that contacts the user's face and surrounds the user's nose and/ormouth. The interface 56 also includes or is connected to a conduitconnector 60 that allows the interface 56 to be connected to one or moregases conduits (not shown). In the illustrated arrangement, the conduitconnector 60 is in the form of an elbow. A headgear 62 is coupled to theinterface 56 and retains the interface 56 in position on the user'sface.

The interface 56, conduit connector 60 and headgear 62 can take on manydifferent forms. For example, the interface 56 can be a nasal interface,which covers only the user's nose, or a full face interface, whichcovers both the nose and mouth. Although a full face interface 56 isillustrated, the present disclosure can apply to other interface typesin which a tube is desired to be passed between the interface cushion orseal and the user's face. The interface 56 can include or omit aforehead rest. In addition, the interface 56 (and, in some arrangements,the conduit connector 60) can be a one-piece structure or, asillustrated, can be an assembly of several components. The illustratedinterface 56 includes a cushion module 64, which in some configurationsincludes a relatively rigid housing 66 and the relatively soft seal 58.The interface 56 also includes a frame 68, which can support the cushionmodule 64 and can provide connection or anchor locations for theheadgear 62. The headgear 62 can be of any suitable arrangement,including single loop or multi loop arrangements.

It is typical for the NG tube 54 to be run from the nose towards thecheek and out the side of the mask 52. In a conventional mask, asillustrated by the dashed lines in FIG. 2, this arrangement can resultin the formation of gaps between the mask seal and a correspondingsurface of the user's face 70. While flexible, the conventional cushionis not capable of conforming to the geometry of the tube 54 to a degreenecessary to prevent undesirably high rates of gas leakage through thegaps between the cushion and the user's face 70. Instead, a relativelylarge length of the cushion lifts away from the user's face 70 andcurves over the tube 54 leaving gaps on either side of the tube 54 whereleaks can occur. In general, the larger the diameter of the NG tube 54,the larger the size of the gaps.

Certain features, aspects and advantages of the present embodiments seekto reduce the gaps that form between the mask cushion 58 and the surfaceof the user's face 70 when an NG tube 54 is used by providing aconformable or compliant region 72 in the mask cushion 58 that canconform to the NG tube 54 to a degree sufficient to create or maintainan adequate seal with the user's face 70. The conformable or compliantregion 72 can be of any suitable arrangement to increase theconformability or compliance of a portion of the cushion 58 relative toadjacent or surrounding portions of the cushion 58. As described herein,the conformable or compliant region 72 can be or comprise a region ofthinned material or a region of different material, among other possiblearrangements.

Preferably, the conformable or compliant region 72 can allow the presentcushion 58 to create or maintain a better seal with the user's face 70than a conventional mask cushion. In some configurations, the presentcushion 58 can accommodate an NG tube 54 with less gas leakage betweenthe cushion 58 and the user's face 70 in comparison to a conventionalcushion. In some configurations, the present cushion 58 can accommodatean NG tube 54 with no or substantially no gas leakage between thecushion 58 and the user's face 70 or gas leakage that is below a rateconsidered to be detrimental to the prescribed therapy. In someconfigurations, the leak rate with the present cushion 58 accommodatingan NG tube 54 within the conformable or compliant region 72 is equal toor less than about 25 L/min at a normal pressure or flow rate range forthe prescribed (e.g., NIV) therapy. In some configurations, the leakrate is less than about 20 L/min, less than about 15 L/min or less thanabout 10 L/min.

FIG. 2 illustrates a profile view of an NG tube 54 passing between thecushion 58 and the user's face 70. The conformable or compliant region72 creates a tube path that is more compliant and flexible than thesurrounding or adjacent portions of the cushion 58. In someconfigurations, the conformable or compliant region 72 is more compliantand flexible than any other portion of the cushion 58. FIG. 2illustrates how the conformable or compliant region 72 stretches anddeforms around the tube 54, which results in much smaller gaps at theside of the tube 54 than a cushion not having the specially configuredtube paths. The size of the gaps will be largely dependent on the tubesize that is being used. In FIG. 2, it is evident that the mask cushion58 does not lift away from the face 70 to accommodate the NG tube 54 tothe same degree as a traditional mask cushion that does not include tubepaths.

The NG tube 54 has a cross-sectional dimension or diameter 74 extendingin a direction away from the user's face 70. Preferably, the conformableor compliant region 72 allows the cushion 58 to contact or conform to atleast a substantial portion of the NG tube 54 that is not in contactwith the user's face 70. In some configurations, the conformable orcompliant region 72 allows the cushion 58 to remain in contact with orconform to at least the outer one-third 76 of the surface of the NG tube54 that is opposite the user's face 70. In some configurations, theconformable or compliant region 72 allows the cushion 58 to remain incontact with or conform to at least the outer one-half 78 of the surfaceof the NG tube 54. In some configurations, the conformable or compliantregion 72 allows the cushion 58 to remain in contact with or conform toat least the outer two-thirds 80 of the surface of the NG tube 54. Insome configurations, the conformable or compliant region 72 allows thecushion 58 to remain in contact with or conform to a substantialentirety of the surface of the NG tube 54 that is not in contact withthe user's face 70.

FIG. 3 illustrates a profile view of the mask cushion 58 of FIG. 2 beingused without an NG tube 54. FIG. 3 illustrates that the conformable orcompliant region 72 sits largely against and contacts the user's skin 70when there is no NG tube 54 present. The external surface of theconformable or compliant region 72 can be shaped such that theconformable or compliant region 72 or tube path substantially followsthe same contours as the rest of the mask cushion 58. Such aconfiguration helps the conformable or compliant region 72 to seal withthe patient's face 70, which will create preferably no more than anegligible leak path in the absence of an NG tube 54. It is beneficialfor the conformable or compliant region 72 to substantially follow thegeometry of the rest of the cushion 58 because such a configuration willmake the mask 52 more versatile and suitable for use on a wider range ofusers than otherwise possible. For example, the illustrated mask 52 canbe used on any user or patient requiring NIV therapy, regardless of theneed for use with tubes. Preferably, the patient-facing or contactingsurface of the conformable or compliant region 72 and the patient-facingor contacting surface of the adjacent or surrounding portions of thecushion 58 define a continuous or uninterrupted surface. That is,preferably, there is no slit or other interruption in the patient-facingor contacting surface within or adjacent to the conformable or compliantregion 72.

In some configurations, there may be a slight step in the externalsurface of the cushion 58. The slight step can be intentional or aresult of the materials, configuration or manufacturing process used tocreate the conformable or compliant region 72. The step can be smallenough that it will generate minimal leaks. The conformable or compliantregion 72 may be flexible enough to inflate under the air pressure thatis applied by the therapy such that the ballooning portion will fill anygaps that a step in the surface may otherwise cause.

As described above, the conformable or compliant region 72 can be of anysuitable arrangement that provides for conformance to the type or sizeof the tube 54 or tubes intended for use with the mask 56. In someconfigurations, the conformable or compliant region 72 is substantiallymore conformable or compliant than surrounding or adjacent portions ofthe cushion 58. In some configurations, the increased conformability orcompliance is at least partially the result of using a differentmaterial in the conformable or compliant region 72 relative tosurrounding or adjacent portions of the cushion 58. For example, theincreased conformability or compliance can be achieved through thelocalized use of a more elastic and flexible material. The differentmaterial can have a higher elasticity or different modulus of elasticitycompared to the material of surrounding or adjacent regions of thecushion 58. Materials can include a different grade of silicone that isless hard or a more flexible TPE, for example but without limitation. Insome configurations, the different material can also have a differentthickness (e.g., less thickness) compared to the material of surroundingor adjacent regions of the cushion 58. The different material can becoupled to the material of surrounding or adjacent regions of thecushion 58 by any suitable process, which can include adhesive orchemical bonding or a co-molding or over-molding process, for exampleand without limitation, or any other appropriate method. In arrangementsin which different material is utilized for the conformable or compliantregion 72, the different material can extend beyond the conformable orcompliant region 72. For example, such an arrangement can provide agreater surface area overlap for bonding of the two materials to oneanother.

In some configurations, the conformable or compliant region 72 is orcomprises a region of thinned material. In the illustrated arrangementsof FIGS. 4-8, the conformable or compliant region 72 comprises a regionof thinned material that is the same material as the material ofsurrounding or adjacent regions of the cushion 58. Thus, the thinnedmaterial region can be unitarily formed with surrounding or adjacentregions of the cushion 58. Hereinafter, the conformable or compliantregion 72 may be referred to as a thin region or thinned region.However, in view of the alternative structures for the conformable orcompliant region 72, such references to a thin region can also generallyinclude other types of conformable or compliant regions, as well. Theconformable or compliant region 72 can define a tube path or tube pathsthat accommodate the passage of the NG tube 54 or other tubes betweenthe cushion 58 and the user's face 70 and, thus, can also be referred toherein as a tube path. In some configurations, the tube path or tubepaths 72 are formed to be thinner than the adjacent portions of thecushion 58. In some configurations, the tube path or tube paths 72 areformed to be thinner than any other portion of the cushion 58.

FIGS. 4-8 illustrate the cushion module 64 separate from other portionsof the mask 52. As described, the cushion module 64 comprises thehousing 66 and the seal or cushion 58. In the illustrated arrangement,the conformable or compliant region 72 of the seal 58 is or comprises athin region. Preferably, the thin region 72 is defined by the seal wall,which thin region 72 is more capable of conforming to the tube 54relative to surrounding, adjacent or other portions of the cushion 58.The cushion 58 generally has a patient face contacting portion or side90 and a portion or side 92 forward of the face contacting portion 90.The face contacting portion 90 is generally rearward-facing and contactsthe user's face 70. The face contacting portion 90 can deform whenplaced into contact with the user's face 70 and an entirety of therearwardly-facing portion may not contact the face of all users or underall circumstances or therapies. In the illustrated configuration, anupper portion of the cushion 58 can be deflected forwardly relative to alower portion of the cushion 58 to better accommodate variations in thenasal geometry of potential users. Examples of such an arrangement aredisclosed in Applicant's PCT Publication No. WO2014/062070, the entiretyof which is hereby incorporated by reference herein and made a part ofthe present disclosure. The cushion 58 can be made from one or moregenerally flexible materials, such as silicone or a TPE, for example butwithout limitation.

A location of the thin region 72 is illustrated by an outline on anexterior surface of the cushion 58 in FIGS. 4 and 5. However,preferably, the thin region 72 is defined by a recess 94 defined by aninterior surface of the cushion 58, as illustrated in FIGS. 6-8. Thegeometry of the thin region 72 can be configured or adapted to conformto a size or shape of the tube(s) intended for use with the mask 52. Insome configurations, the thin region 72 can be positioned at leastpartially or entirely within the face contacting portion 90 of thecushion 58. With reference to FIG. 5, the thin region 72 extendsgenerally in a direction from an inner edge 96 of the face contactingportion 90 towards an outer edge 98 of the face contacting portion 90.In some configurations, the thin region 72 can be spaced from one orboth of the inner edge 96 and the outer edge 98. In some configurations,as illustrated in FIG. 4, the thin region 72 can extend beyond the outeredge 98 of the face contacting portion 90 and into the forward portion92 of the cushion 58.

In some configurations, the thin region 72 is angled relative to ahorizontal axis 100 of the cushion 58 or cushion module 64. A verticalaxis 102 can bisect the cushion 58 or cushion module 64 in a verticaldirection and the horizontal axis 100 is perpendicular to the verticalaxis 102 and extends in a lateral direction of the cushion 58 or cushionmodule 64. An axis 104 of the thin region 72 and the horizontal axis 100can define an angle therebetween of between about 5 degrees and about 45degrees, or more if desired. In one configuration, the angle between theaxis 104 and the horizontal axis 100 is about 20 degrees. In theillustrated arrangement, an inner end 106 of the thin region 72 closerto the centerline or vertical axis 102 is higher than an outer end 108of the thin region 72 that is further from the centerline or verticalaxis 102. Such an arrangement accommodates the typical path of the NGtube 54 as illustrated in FIG. 1. However, the thin region 72 can beprovided in other orientations to suit other applications, as desired.For example, an oro-gastric (OG) tube may extend through the cushion 58at about 0 degrees or generally along the horizontal axis 100. Thus, thespecific orientation of the thin region 72 can be selected as desired inview of the particular tube, tube orientation or other relevant factors.

The thin region 72 can have any suitable size or shape to configured oradapted to conform to a size or shape of the tube(s) intended for usewith the mask 52. In the illustrated arrangement, the thin region 72defines substantially linear side edges 110 and 112 extending betweenthe inner end 106 and the outer end 108. The side edges 110 and 112 canbe substantially parallel to one another. The axis 104 can be defined asa line parallel to an equidistant from the side edges 110, 112. In someconfigurations, one or both of the inner end 106 and the outer end 108can have a rounded or substantially semi-circular profile, as shown inFIGS. 4 and 5. This geometry will result in the thicker side-wallstructure of the cushion 58 butting up to the circumference of the NGtube 54, and the thin region 72 deforming between the thicker side-walland the tube 54. The thin region 72 can be thin enough to deform andstretch over an NG tube 54 for which the mask 52 is intended or approvedfor use without significantly lifting the cushion 58 away from thepatient's face 70. In some configurations, no lift or substantially nolift will occur. The rounded geometry of the ends 106, 108 of theconforming region 72 can minimize the likelihood of the NG tube 54 beingdeformed or constricted by the relatively thicker adjacent wall portionof the cushion 58.

FIGS. 6-8 show cross-sectional views of the thin conforming region 72 ofthe cushion 58. In the illustrated configuration, the internal surfaceof the cushion 58 may reduce or step down from a relatively thicker wallsection to the relatively thinner and more conformable portion 72 todefine the interior recess 94 while the external surface can remainsubstantially unchanged. In other words, the external surface iscontinuous and uninterrupted between the thin region 72 and the adjacentor surrounding portions of the cushion 58. However, in someconfigurations, the external surface could include a recess in additionto or in the alternative to the internal recess 94 and ballooning aresult of internal gas pressure could be relied on to create a seal withthe user's face 70 in the absence of a tube 54.

The recess 94 can define a length 114 in a direction along the axis 104and a height 116 in a direction perpendicular to the axis 104. Thelength 114 can be selected to extend along a length of the facecontacting portion 90 that is likely to be in contact with the user'sface 70 under typical or expected operating conditions. In someconfigurations, the length 114 is between about 15 mm and about 20 mm.The length 114 can vary with the size of the cushion 58 or can remainconstant between different sized cushions 58. For example, the length114 can vary from about 15.5 mm in a small cushion 58 to about 19 mm or19.3 mm for a large cushion 58. The height 116 can be selected toaccommodate the diameter or cross-sectional dimension of the tube(s)with which the mask 52 is designed or intended to be used. In someconfigurations, the height 116 is substantially equal to somewhat largerthan the diameter of the maximum tube size with which the mask 52 isdesigned or intended to be used. In some configurations, the height 116is between about 5 mm and about 15 mm, or between about 10 mm and 12 mm.The height 116 can vary with the size of the cushion 58, such as about 9mm for an extra small cushion, about 10 mm for a small and mediumcushion and about 11 mm for a large cushion. Alternatively, the height116 can remain constant between cushion sizes.

The thin region 72 defines a wall thickness 118 that is less than a wallthickness 120 of portions of the cushion 58 adjacent to or surroundingthe thin region 72. Preferably, the wall thickness 118 of the thinregion 72 is less than the wall thickness 120. In some configurations,the wall thickness 118 is about 5 percent to about 80 percent or about10 percent to about 30 percent of the wall thickness 120. In someconfigurations, the wall thickness 118 represents a reduction inthickness relative to the wall thickness 120 of between about 70 percentto about 95 percent, or about 80 percent to about 90 percent. Forexample, in some configurations, the wall thickness 120 can be about1.49 or 1.5 mm and the wall thickness 118 can be between about 0.1 mmand about 0.5 mm, or between about 0.15 mm and about 0.3 mm. In someconfigurations, the wall thickness 118 is about 0.3 mm. The wallthickness 118 within the recess 94 is illustrated as substantiallyconstant (not including the transition portions between the recess 94and the surrounding or adjacent portions of the cushion 58). However, inother arrangements, the wall thickness 118 can vary within the recess94.

The cushion 58 can define a depth 121 (FIG. 8) in a forward-rearwarddirection from a rearward most point on the patient contacting portion90 at a height of the thin region 72 and a location of the outer end 108of the thin region 72. Having a sufficient depth 121 can assist thecushion 58 to remain in contact with the user's face 70 with an NG tube54 in place. However, preferably, the depth 121 is not too large, or thethin region 72 does not extend too far toward or into the forwardportion 92 of the cushion 58 to avoid unnecessary weakening of thecushion 58. The depth 121 can be related to the size of tube 54 withwhich the mask 52 is designed, intended or approved for use. In someconfigurations, the depth 121 is between about 10 mm and about 20 mm, orbetween about 15 mm and about 18 mm. The depth 121 can vary with thesize of the cushion 58, such as about 14 mm or 14.3 mm for an extrasmall cushion, about 15.7 mm or about 16 mm for a medium cushion andabout 17.8 mm or 18 mm for a large cushion. Alternatively, the depth 121can remain constant between cushion sizes.

In some configurations, the transition in thickness between the recess94 and the adjacent or surrounding portions of the cushion 58 can berelatively abrupt. The abrupt transition can create a fold point thatrestricts deformation that may be caused by a tube to the relativelythinner region 72 of the cushion 58. The relatively thinner region 72can deform, stretch and/or bunch up until a relatively thicker wallportion is encountered, which can limit any further deformation. Inother configurations, the transition in thickness can be less abrupt, asillustrated by the dashed lines at the edges of the recess 94 in FIG. 7.A smooth or less abrupt transition may be preferred for other reasons,such as manufacturability reasons, for example. Preferably, thetransition is limited to a relatively small distance from the recess 94or relatively small area surrounding the recess 94. For example, thetransition can be substantially linear and/or can be an angle sufficientto allow the practical removal of a molded cushion 58 having the thinregion 72 from a mold. In some configurations, the transition regionpreferably extends away from the thin region 72 a distance of no morethan the width or length of the thin region 72 and, preferably, extendsno more than a portion of the width or length of the thin region 72(e.g., less than one-half, one-third or one-quarter of the width orlength of the thin region 72).

FIG. 9 illustrates one example of an outline of a recess or thin region72 in a flattened condition. In practice, the thin region 72 is likelyto be curved or three-dimensional in shape because many patentcontacting surfaces of mask cushions are curved in lateral and/orvertical directions. In FIG. 9, each end 106, 108 of the thin region 72is semi-circular in shape about a respective center 122. Thus, adistance 124 between the centers 122 plus the radius of each end 106,108 equals the overall length 114 of the thin region 72. In theillustrated thin region 72, the side edges 110, 112 are parallel to oneanother and each end 106, 108 is of an equal radius. However, in otherarrangements, the thin region 72 can have other suitable shapes.

In some configurations, such as that shown in FIG. 10, the conformingthin regions or tube paths 72 can be provided in multiple locations.FIG. 10 shows a rear view of the cushion 58 with two tube paths 72spaced from one another along a perimeter of the cushion 58 andsymmetrically located on each side of the mask 52. Having paths 72 oneach side of the mask 52 allows for an NG tube 54 to be secured toeither side of the patient's face 70. It is common practice for NG tubes54 to be alternated between a patient's nostrils in order to reduceirritation and tissue damage within the nasal passage. Havingsymmetrical tube paths 72 on the mask 52 enables a clinician to changethe side that the NG tube 54 is secured to and to continue to use thesame mask 52. Such a configuration reduces wastage of equipment and mayreduce work for the clinicians. Additionally, having tube paths 72 onboth sides enables a cushion 58 to seal when both an NG tube 54 and anNJ tube are in simultaneous use.

Also shown in FIG. 10 are two different tube path 72 sizes. Because NGtubes 54 come in a variety of sizes, it is beneficial for the tube paths72 to be able to conform to any size or at least commonly used sizes. Itmay be desired to have more than one path size in a mask 52 in order tocover a wider range of tube diameters with at least acceptable leak-rateperformance. If a tube is too small for the tube path 72, the relativelythicker wall section of the cushion 58 may not be able to adequatelyrestrict the deformation of the thin region 72 and gaps may form, whichgaps can result in leaks. The size of the tube path 72 can be defined tosuit a certain range of tube diameters. It is desirable for theround/circular profile of the tube path 72 to generally correlate to ormatch the tube diameter, as discussed above. By closely matching orgenerally correlating the tube path 72 to the tube 54, the relativelythicker wall section can force the thin region 72 to conform around thetube 54.

It is preferable not to have too many tube paths 72 or tube paths 72that are too large because they can reduce the structural integrity ofthe cushion 58. The relatively thicker wall-section of the cushion 58can be designed to provide structure and support to the mask 52. Thecushion 58 can be provided with structure to reduce or eliminate thelikelihood of the cushion 58 collapsing when the mask 52 is strapped onto a patient 50. If the cushion 58 collapses, leaks can occur and therigid plastic mask frame 68 can be pushed against the patient's face 70causing discomfort. Therefore, the number and size of tube paths 72 maybe limited so that the structure of the cushion 58 is less likely to becompromised. The cushion 58 can include any single one or anycombination of the tube paths 72 illustrated in FIG. 10, for example. Insome configurations, the cushion 58 can include a single tube path 72 onone side or a single tube path 72 on each side. In configurations withat least one tube path 72 on each side, the tube paths 72 can be thesame size or a different size. For example, the cushion 58 can include arelatively smaller tube path 72 on one side and a relatively larger tubepath 72 on the other side. In some configurations, the cushion 58includes a small and a large tube path 72 on each side.

Typically, NG tubes 54 are run from the underside of a patient's noseacross their lip and out across the cheek. The tube 54 usually issecured to the nose with tape. The one or more tube paths 72 preferablyare located on the cushion 58 such that they align approximately withthe lower surface of a patient's nose or somewhat lower so that thetubes 54 can be secured to the patient 50 in approximately theconventional location for ease of use by the clinician. It can bebeneficial for the tube 54 to be positioned over the soft part of apatient's cheek, anywhere below the zygomatic bone, to minimize theoccurrence of pressure sores. Having the tube paths 72 located in such away on the cushion 58 will enable clinicians to continue usingtraditional techniques for fitting and securing NG tubes 54. In someconfigurations, the tube paths 72 are located in the lower half of thecushion 58 or the lower third of the cushion 58. The tube paths 72 canbe located at, near or somewhat above a widest point of a full facecushion 58. In some configurations, the tube paths 72 are spaced above alowermost point of an inner edge of the cushion 58.

FIGS. 11A and 11B show embodiments of a cushion module 64 of a mask 52having visual alignment indicators 130. The indicators 130 are intendedto provide clinicians with a visual cue for aligning a mask 52 over thetop of an NG tube 54 on a patient's face 70. For the illustrated masks52 to work effectively, it is desirable for the NG tube 54 to be alignedaccurately with respect to the tube paths 72 on the mask cushion 58.Misalignment may result in increased leak rates. The alignmentindicators 130 can be in the form of an arrow and label that pointtowards the NG tube path 72. The indicator 130 may be located on thecushion 58, as illustrated in FIG. 11A, or the mask body (e.g., housing66 or frame 68), as illustrated in FIG. 11B, proximate to the tube path72. Embossing, printing, laser etching, molding or other markingtechniques can be used to form the indicator 130 on the mask 52.

Unless the context clearly requires otherwise, throughout thedescription and the claims, the words “comprise”, “comprising”, and thelike, are to be construed in an inclusive sense as opposed to anexclusive or exhaustive sense, that is to say, in the sense of“including, but not limited to”. Conditional language used herein, suchas, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like,unless specifically stated otherwise, or otherwise understood within thecontext as used, is generally intended to convey that certainembodiments include, while other embodiments do not include, certainfeatures, elements and/or states. Thus, such conditional language is notgenerally intended to imply that features or elements are in any wayrequired for one or more embodiments.

The term “plurality” refers to two or more of an item. The term “about”or “approximately” means that quantities, dimensions, sizes,formulations, parameters, shapes and other characteristics need not beexact, but may be approximated and/or larger or smaller, as desired,reflecting acceptable tolerances, conversion factors, rounding off,measurement error and the like and other factors known to those of skillin the art. The term “substantially” means that the recitedcharacteristic, parameter, or value need not be achieved exactly, butthat deviations or variations, including for example, tolerances,measurement error, measurement accuracy limitations and other factorsknown to those of skill in the art, may occur in amounts that do notpreclude the effect the characteristic was intended to provide.

Numerical data may be expressed or presented herein in a range format.It is to be understood that such a range format is used merely forconvenience and brevity and thus should be interpreted flexibly toinclude not only the numerical values explicitly recited as the limitsof the range, but also interpreted to include all of the individualnumerical values or sub-ranges encompassed within that range as if eachnumerical value and sub-range is explicitly recited. As an illustration,a numerical range of “about 1 to 5” should be interpreted to include notonly the explicitly recited values of about 1 to about 5, but shouldalso be interpreted to also include individual values and sub-rangeswithin the indicated range. Thus, included in this numerical range areindividual values such as 2, 3 and 4 and sub-ranges such as “about 1 toabout 3,” “about 2 to about 4” and “about 3 to about 5,” “1 to 3,” “2 to4,” “3 to 5,” etc. This same principle applies to ranges reciting onlyone numerical value (e.g., “greater than about 1”) and should applyregardless of the breadth of the range or the characteristics beingdescribed.

A plurality of items may be presented in a common list for convenience.However, these lists should be construed as though each member of thelist is individually identified as a separate and unique member. Thus,no individual member of such list should be construed as a de factoequivalent of any other member of the same list solely based on theirpresentation in a common group without indications to the contrary.Furthermore, where the terms “and” and “or” are used in conjunction witha list of items, they are to be interpreted broadly, in that any one ormore of the listed items may be used alone or in combination with otherlisted items. The term “alternatively” refers to selection of one of twoor more alternatives, and is not intended to limit the selection to onlythose listed alternatives or to only one of the listed alternatives at atime, unless the context clearly indicates otherwise.

Reference to any prior art in this specification is not, and should notbe taken as, an acknowledgement or any form of suggestion that thatprior art forms part of the common general knowledge in the field ofendeavour in any country in the world.

Where, in the foregoing description reference has been made to integersor components having known equivalents thereof, those integers areherein incorporated as if individually set forth.

The invention may also be said broadly to consist in the parts, elementsand features referred to or indicated in the specification of theapplication, individually or collectively, in any or all combinations oftwo or more of said parts, elements or features.

It should be noted that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications may be madewithout departing from the spirit and scope of the invention and withoutdiminishing its attendant advantages. For instance, various componentsmay be repositioned as desired. It is therefore intended that suchchanges and modifications be included within the scope of the invention.Moreover, not all of the features, aspects and advantages arenecessarily required to practice the present invention. Accordingly, thescope of the present invention is intended to be defined only by theclaims that follow.

What is claimed is:
 1. A cushion for a respiratory mask having a maskbody, which includes the cushion, the respiratory mask being configuredfor connection to a gases delivery conduit for supply of breathing gasesto a user, the cushion comprising: a face contacting portion configuredto contact a face of the user and surround the nares and/or mouth of theuser; at least one thin region at least partially within the facecontacting portion, the at least one thin region being more compliantthan adjacent portions of the cushion such that the at least one thinregion is configured to accommodate the placement of a tube between anouter surface of the face contacting portion and the face of the user bystretching and deforming around the tube; an opening defined by an inneredge of the face contacting portion, the opening comprising an uppermostextent and a lowermost extent; wherein the at least one thin region isconfigured such that with the tube in place and in contact with theouter surface, the cushion creates a seal sufficient to maintain anefficacy of a prescribed therapy; wherein the outer surface of the atleast one thin region contacts the face of the user when the tube is notin place; wherein an entirety of the outer surface of the facecontacting portion within the at least one thin region defines acontinuous surface; wherein an entirety of the at least one thin regionis located in a portion of the face contacting portion defined by theuppermost extent and the lowermost extent of the opening.
 2. The cushionof claim 1, wherein the at least one thin region comprises a first thinregion and a second thin region located on a respective one of opposinglateral sides of the face contacting portion.
 3. The cushion of claim 2,wherein the first thin region is relatively larger than the second thinregion.
 4. The cushion of claim 1, wherein the at least one thin regioncomprises at least a first thin region and a second thin region on onelateral side of the face contacting portion.
 5. The cushion of claim 4,wherein a first thin region and a second thin region are spaced apartfrom one another.
 6. The cushion of claim 5, wherein the first thinregion and the second thin region are spaced apart along a perimeter ofthe face contacting portion.
 7. The cushion of claim 6, wherein the twoor more thin regions comprises at least one relatively larger thinregion and at least one relatively smaller thin region.
 8. The cushionof claim 1, wherein the at least one thin region extends in a directionfrom the inner edge of the face contacting portion toward an outer edgeof the face contacting portion.
 9. The cushion of claim 1, wherein theat least one thin region extends downwardly relative to a horizontalaxis from an inner end portion to an outer end portion.
 10. The cushionof claim 9, wherein the at least one thin region extends downwardly atan angle of between about 5 degrees and about 45 degrees.
 11. Thecushion of claim 1, further comprising a smooth transition in thicknessbetween the at least one thin region and an adjacent portion of the facecontacting portion.
 12. The cushion of claim 11, wherein the transitionis substantially linear.
 13. The cushion of claim 1, wherein a thicknessof the at least one thin region is between about 5 percent and about 80percent of a thickness of an adjacent portion of the face contactingportion.
 14. The cushion of claim 13, wherein the thickness of the atleast one thin region is between about 10 percent and about 30 percentof the thickness of the adjacent portion of the face contacting portion.15. The cushion of claim 1, wherein end portions of the at least onethin region are rounded.
 16. The cushion of claim 1, wherein an innerend portion of the at least one thin region is spaced outwardly from theinner edge of the face contacting portion.
 17. The cushion of claim 1,wherein an outer end portion of the at least one thin region is spacedinwardly from an outer edge of the face contacting portion.
 18. Thecushion of claim 1, wherein the tube is a feeding tube.
 19. The cushionof claim 1, further comprising a visual alignment indicator thatindicates a proper location of the tube.
 20. A patient interface,comprising: a cushion according to claim
 1. 21. The patient interface ofclaim 20, wherein the cushion is adapted to create a seal around theuser's nose and/or mouth.
 22. The patient interface of claim 20, whereinthe cushion is configured such that an upper portion of the cushion canbe deflected forward relative to a lower portion of the cushion.
 23. Thepatient interface of claim 20, further comprising headgear adapted toretain the patient interface on the head of a user.
 24. The patientinterface of claim 23, further comprising a frame portion adapted tointerface with the headgear, wherein the cushion is adapted to interfacewith the frame portion.
 25. The patient interface of claim 20, whereinthe cushion comprises a relatively soft portion defining the facecontacting portion and a relatively rigid portion facing away from therelatively soft portion.
 26. The cushion of claim 15, wherein the atleast one thin region comprises two side edges that are parallel to oneanother.
 27. The cushion of claim 26, wherein the rounded end portionsof the at least one thin region are connected by the two side edges. 28.A respiratory mask configured for connection to a gases delivery conduitfor supply of breathing gases to a user, the mask comprising: a maskbody comprising an inflatable seal configured to create a seal with aface of the user, wherein the inflatable seal comprises: a facecontacting portion defining an uninterrupted external face contactingsurface configured to contact the face of the user and define aperimeter that surrounds the nares and/or mouth of the user; at leastone thin region at least partially within the face contacting portionand defining a portion of the face contacting surface, the thin regionbeing more compliant than adjacent portions of the face contactingsurface of the inflatable seal such that the at least one thin region isconfigured to accommodate the placement of a tube between the externalsurface of the face contacting portion and the face of the user bystretching and deforming around the tube.
 29. The respiratory mask ofclaim 28, wherein the at least one thin region is configured to conformto a shape of the tube while substantially maintaining an adequate sealwith the face of the user.
 30. A respiratory mask configured forconnection to a gases delivery conduit for supply of breathing gases toa user, the mask comprising: a rigid housing; and an inflatable sealconfigured to create a seal with a face of the user, wherein theinflatable seal comprises: a face contacting wall portion having anexterior surface configured to contact the face of the user and surroundthe nares and/or mouth of the user; a side wall portion located betweenthe face contacting wall portion and the housing; at least one thinregion at least partially within the face contacting wall portion anddefined at least partially by the exterior surface, the at least onethin region having a smaller wall thickness between an interior surfaceof the face contacting wall portion that faces an interior space of therespiratory mask and the exterior surface, the at least one thin regionbeing more compliant than adjacent portions of the inflatable seal suchthat the at least one thin region is configured to accommodate theplacement of a tube between the surface of the face contacting wallportion and the face of the user.
 31. The respiratory mask of claim 30,wherein the at least one thin region is configured to conform to a shapeof the tube while substantially maintaining an adequate seal with theface of the user.